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Standard Operating Procedure

ViscoQC 300 [with PTD 80]


SOP for Pharma Qualification Package

This SOP takes effect from the date of its approval, replacing the previous
version. Only the original SOP or copies authorized by the responsible
Quality Assurance Officer may be used.

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Standard Operating Procedure
ViscoQC 300 [with PTD 80]
SOP for Pharma Qualification Package

Table of Contents
1 Purpose............................................................................................................................................................... 3
2 Scope.................................................................................................................................................................. 3
3 Definitions............................................................................................................................................................ 3
4 Responsibilities................................................................................................................................................... 3
5 Procedure............................................................................................................................................................ 3
5.1 Switching the Instrument On / Off.............................................................................................................................................................4
5.2 Connecting Optional Input / Output Devices.............................................................................................................................................4
5.2.1 Data Input..............................................................................................................................................................................................4
5.2.2 Data Output...........................................................................................................................................................................................5
5.3 Log On.......................................................................................................................................................................................................6
5.4 Level / Zero Adjustment.............................................................................................................................................................................6
5.5 Edit a Measurement Method – Options.....................................................................................................................................................7
5.6 Select a Measurement Method...............................................................................................................................................................13
5.6.1 Manual Mode Settings – Options........................................................................................................................................................13
5.6.2 [ Setting the PTD 80 measuring temperature in Manual Mode ]........................................................................................................14
5.7 Performing Measurements......................................................................................................................................................................14
5.7.1 Measuring with Spindles.....................................................................................................................................................................15
5.7.2 Measuring with DIN/SSA Systems.....................................................................................................................................................17
5.7.3 [Measuring with DIN/SSA Systems with PTD 80]...............................................................................................................................18
5.7.4 Measurement Procedure....................................................................................................................................................................20
5.7.4.1 Measuring in Manual Mode (MM)..............................................................................................................................................21
5.8 Cleaning...................................................................................................................................................................................................23
5.8.1 Removing and Cleaning Wetted Parts................................................................................................................................................23
5.8.2 Cleaning the Instrument......................................................................................................................................................................24
5.8.2.1 [Cleaning PTD 80]......................................................................................................................................................................24
6 Documentation.................................................................................................................................................. 24
7 Safety and Environmental Details...................................................................................................................... 24
8 References........................................................................................................................................................ 25
9 Modification Index.............................................................................................................................................. 25

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Standard Operating Procedure
ViscoQC 300 [with PTD 80]
SOP for Pharma Qualification Package

1 Purpose
The correct use of the ViscoQC 300 Rotational Viscometer [and the temperature device PTD 80] 1 manufactured by
Anton Paar GmbH is essential to receive correct and valid data.
This SOP “Standard Operating Procedure ViscoQC 300 [with PTD 80]” is a guideline for the customer to handle the
instrument correctly. It is part of the Anton Paar qualification documentation offered together with the instrument.
This SOP represents a template and is intended for direct use in the QM system of the respective customer. It has
to be adapted, reviewed and approved to comply with the customer’s internal QM regulations.

2 Scope
This SOP defines how to handle the ViscoQC 300 Rotational Viscometer [and the temperature device PTD 80] to
receive correct measurement results.
This SOP addresses all users, lab managers and administrators as well as the Responsible User and Quality
Assurance Officer.

3 Definitions
ViscoQC 300 ViscoQC 300 Rotational Viscometer
[PTD 80 Peltier Temperature Device PTD 80]
USB Printer Label Printer USB Dymo® 450
SOP Standard Operating Procedure
QM Quality Management
CC Concentric cylinder
DG Double-gap
CC12/D18 Bob of measuring system CC12 with disposable measuring cup D18
SSA Small Sample Adapter (measuring systems consisting of SC4 spindles and CC18 cup)
V Vane spindles
LIMS Laboratory Information Management System

4 Responsibilities
The responsibility for the creation, correctness and internal compliance with internal regulations of this SOP lies
with the Quality Assurance Office at the customer.

5 Procedure
This SOP explains the steps for correct handling of the ViscoQC 300 [in combination with a PTD 80].
The instrument is fully installed and tested by the Anton Paar representative and ready for daily operation. During
installation, system security settings (see Appendix C of the Instruction Manual and Safety Information,
C78IB007EN, Menu Tree) have been defined in accordance with user regulations.

1
[Text in square brackets applies to the use of temperature device PTD 80.]
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Standard Operating Procedure
ViscoQC 300 [with PTD 80]
SOP for Pharma Qualification Package

5.1 Switching the Instrument On / Off

 ViscoQC 300 must be connected to the power supply and the


power supply to the mains.

 Make sure that the transport protection ( ) was removed


from the coupling and that no spindle is connected.
See arrow.

 To switch ViscoQC on, set the power switch on the rear side of
the measuring head to " I ".
The display on the front side lights up. [The PTD 80 is
connected to the ViscoQC via CAN cable and is activated
together with the instrument. The PTD 80 LED on the front side
blinks.]

 To switch ViscoQC 300 [and the PTD 80] off, set the power


switch to " 0 ".
Figure 1: Switch on ViscoQC 300

5.2 Connecting Optional Input / Output Devices


ViscoQC features three USB interfaces and one Ethernet interface.

5.2.1 Data Input

Optional input devices with USB cable

– Keyboard – 2D bar code scanner (for sample names)

Figure 2: Three USB interfaces for input/output Figure 3: Input devices keyboard and bar code scanner
devices

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Standard Operating Procedure
ViscoQC 300 [with PTD 80]
SOP for Pharma Qualification Package

5.2.2 Data Output

Anton Paar LIMS Bridge Software allows the data transfer for
implementation in LIMS: Use the Ethernet interface and a suitable
Ethernet cable (CAT5e, RJ45G-RJ45G, SFTP, 2 m, Crossed).
See Figure 4.

1. Plug the Ethernet cable into the Ethernet interface of


ViscoQC.
2. Connect the other end of the cable to an Ethernet port of your
local network or to your PC (the PC needs an active local
network connection).
3. If connecting the ViscoQC to a PC, deactivate the option
"Obtain an IP address automatically (DHCP)" (Menu > Setup
> Control Panel > Network):
Figure 4: One Ethernet interface for data output
LIMS Bridge Settings are defined during initial installation. Refer to
the LIMS Bridge Reference Guide. Consider the following directions:
 ViscoQC does not support LIMS Import => deactivate this
setting
 ViscoQC does not support Check Data Import => deactivate
this setting
 For export of measurement data, adjustment data, and audit
trail data use format CSV or PDF.
TIP: Activating PDF reports significantly influences the GUI
performance of ViscoQC 300. It is therefore recommended to perform
manual export as "General Purpose Export" for audit trail and
Figure 5: Ethernet cable (crossover) for data output
adjustment data.

Label Printer USB Dymo® 450, label size of 36 mm x 89 mm


This label also supports date/time, user name, mode, ….
Recommended for a maximum of five measuring points only!
1. First, connect the printer cable to the printer.
2. Then plug the printer cable into the USB interface of ViscoQC
(see Figure 2, p. 4).
3. Connect the printer to the mains. Follow the safety and
operating instructions of the printer’s documentation.

Figure 6: Label Printer USB Dymo® 450 for printing


measurement data on labels TIP: If Automatic Printout is active, and this printer type is selected,
ViscoQC 300 automatically prints, when a measurement is finished.
NOTE: The printer can only print labels with very limited data:
– ViscoQC model and serial number
– spindle/measuring system info (+ unique ID)
– measurement mode and data
– if applicable: up to 3 warning/error numbers

USB storage device: If in accordance with the system security


settings, you can export data export to a USB storage device.
1. Connect the USB storage device to a free USB interface (see
Figure 2, p. 4).
2. Select the USB storage device as storage location for export
Figure 7: USB storage device
or printout.

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Standard Operating Procedure
ViscoQC 300 [with PTD 80]
SOP for Pharma Qualification Package

5.3 Log On
Log on with your user name and password.
1. Enter your user name.
1. Enter your password.
2. Tap <OK>.
Depending on your user group and rights, you have access to the
different functionalities of ViscoQC 300. Find the default users and
user groups in the ViscoQC 300 Instruction Manual. This manual also
explains how to customize user groups and how to create new users.
User groups and users have been customized during initial
Figure 8: Log on installation.

5.4 Level / Zero Adjustment


Level Adjustment

Level ViscoQC by turning the two leveling screws on the foot of the
stand. An adjusted, built-in leveling chip serves as reference.
Center the colored dot in the colored ring (steps A to C).

 a: RED – Adjust the two leveling screws.

 b: YELLOW – Wait; the instrument stabilizes.

 c: GREEN – ViscoQC is correctly leveled.

Figure 9: Level ViscoQC 300  Tap <OK> to continue.

Zero Adjustment

For correct function of ViscoQC, the instrument determines the start


position for zero torque without load (i.e. no spindle or measuring
system is attached).

1. ViscoQC prompts you to remove the spindle.


Tap <Next> to continue.

2. ViscoQC performs a Zero Adjustment. Do not touch the


instrument. ViscoQC 300 gives a message when the Zero
Adjustment is successfully finished.

3. [If a PTD 80 is connected, tap <Next> in order to level the


PTD 80].
[ ]
Figure 10: Steps of Zero Adjustment

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Standard Operating Procedure
ViscoQC 300 [with PTD 80]
SOP for Pharma Qualification Package

[Leveling the PTD 80]

4. [As final step of the start-up procedure, level the PTD 80:


Turn the adjustable screws (3 pcs. – see arrows) until the
colored dot is centered in the ring and turns green.]

[Figure 11: Leveling the PTD 80]

5. Tap <OK>. Now ViscoQC is ready for operation.

Figure 12: <OK> when Level/Zero Adjustment


successfully finished

5.5 Edit a Measurement Method – Options


The base model of ViscoQC 300 features seven default methods, which are described in the ViscoQC 300
Instruction Manual. All methods are named after the employed measurement mode and start with the letters "AP".

Method name: Measurement Mode


 AP Manual Mode: Manual Mode (MM)
 AP Speed Scan: Speed Scan (SpS)
 AP Stop at Temperature: Stop at Temperature (@T) – with Pt100 sensor only [ / not with PTD 80 ]
 AP Stop at Time: Stop at Time (@t)
 AP Stop at Torque: Stop at Torque (@M) – "M" = Latin "momentum"
 AP Stop at Viscosity: Stop at Viscosity (@V)
 [ AP Temperature Scan: Temperature Scan (TS) ]
 AP Time Scan: Time Scan (TiS)

With software package V-Curve, two additional default methods are available:
 AP Programmed Steps: Steps (StP)
 AP Yield Point: Yield Stress (YiS)

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Standard Operating Procedure
ViscoQC 300 [with PTD 80]
SOP for Pharma Qualification Package

You cannot edit default methods. To customize a method, copy


the default method, which best fits your requirements.
By tapping on the list headers, you can sort the methods either by
name, mode or visibility.

1. Tap <Menu>.

2. Select "Method Settings".

3. Press > 3 seconds on a method in order to copy it.

Button <More> allows you to create or delete methods,


and to set their visibility. Users cannot select invisible
methods for measuring.

4. Tap copy.

5. Tap the copied method in order to edit it.

6. If you create or edit a method, define the following


settings. Each method has mode-specific and general
settings. See below, Table 1.

Figure 13: Copy and edit a method

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Standard Operating Procedure
ViscoQC 300 [with PTD 80]
SOP for Pharma Qualification Package
Table 1: Method settings depending on the selected measurement mode

ViscoQC 300 Base Model V-Curve activated

Stop @ Temp.
Manual Mode Speed Scan Stop @ Time Stop @ Stop @ Time Scan Yield Stress
(@T) [not with Steps (StP)
(MM) (SpS) (@t) Torque (@M) Viscosity (@V) (TiS) (YiS)
PTD 80]
Single point Multi point Single point Single point Single point Single point Multi point Yield point Combine

+ +
Method Name (enter a method name)
Measurement Mode (select mode, according to table header) Use Steps 
Specific Method Settings
- Speed List - Parameter of - Parameter of - Parameter of - Parameter of - Parameter of - Parameter of - Preshear time - Steps
Items set value set value set value set value set value set value - Preshear
(Set Speed or (Speed List, (TruMode – (Speed List, (Speed List, (Speed List, speed Select a
Create, select Shear Rate) Set Speed or see Set Speed or Set Speed or Set Speed or - Zeroing measurement
or unselect - Start Set Shear Rate) 5.6.1/p. 14, Shear Rate) Shear Rate) Shear Rate) - Zero speed mode for
preset Value - Set Value Speed List, - Set Value - Set Value - Set Value - Wait after each step.
speeds, - Stop Set - Target Pt100 Set Speed or - Target - Target Dyn. - Preshear zero Available
which are Value Temperature Shear Rate) Torque Viscosity Time - Run speed modes and
available in - Number of - Set Value - Target Time - Torque specific
the Speed Points - Target Time - Step Width Reduction settings are
List in the - Distribution - Overtime the same as
Manual Mode type for the other
- Preshear methods in
Time this table.
- Target Time
[ with PTD 80 only: - Set Temperature (enter a measuring temperature value)
- T-Ready (disabled: Measurement starts when "Sensor ready", i.e. the internal Pt100 sensor of the PTD 80 is at set temperature.
enabled: Additional stability criteria ensure that measurement starts only if also the sample in the cup is at set temperature.) ]
>>> continues on next page
Table 1: Method settings depending on the selected measurement mode <<< continued from previous page

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Standard Operating Procedure
ViscoQC 300 [with PTD 80]
SOP for Pharma Qualification Package
ViscoQC 300 Base Model V-Curve activated
(MM) (SpS) (@T) (@t) (@M) (@V) (TiS) (YiS) (StP)
General Method Settings
- Display Layout (select: 4 / 5 / 6 Widgets | V-Curve 2: 1 Graph + 5 or 6 Widgets)
- Immersion Depth for spindles: Full (default) / Half – applies to V71 to V73 only
- Restrict use of spindles (enable/disable)
- Restrict to Unique Spindle Identifier (enable/disable)
- Allowed Spindles (if enabled, select from spindle list)
- Use Limits (enable/disable)
- Limits (if enabled, set limits => quantities and values)
- Use operator instructions (enable/disable):
- Operator instruction text (if enabled, enter max. 100 characters)
- Density: 1.000 g/cm³ – default value, range: 0.0000 g/cm³ to 9.9999 g/cm³
––– Math. Model2 ––– ––– ––– ––– Math. Model2 ––– Math. model
Quick Settings: It depends on the settings in the User Group Administration, which users can change parameters in the quick
settings. It is possible to access the quick settings without full access rights to method settings.
- Sample Name is mandatory (enable/disable)
- Show Set Value (enable/disable)
––– –––
- Set Value is mandatory (enable/disable)
- Density Input (enable/disable)
- Density Input is mandatory (enable/disable)
- Show Immersion Depth for Spindles (enable/disable)
- Immersion Depth is mandatory (enable/disable)
- Show Batch Number (enable/disable)
- Batch Number is mandatory (enable/disable)
- Show AR Number (enable/disable)
- AR Number is mandatory (enable/disable)
- Show Custom (enable/disable)
- Custom Name (enter a name for the custom field)
- Custom is Mandatory (enable/disable)

2
Choice only available if software package V-Curve has been activated

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Standard Operating Procedure
ViscoQC 300 [with PTD 80]
SOP for Pharma Qualification Package
[ Table 2: Method settings for Temperature Scan – only in combination with PTD 80 ]

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Standard Operating Procedure
ViscoQC 300 [with PTD 80]
SOP for Pharma Qualification Package
ViscoQC 300 Base Model

Temperature Scan (TS)

Multi point

Method Name: default: AP Temperature Scan – enter a method name


Measurement Mode: Temperature Scan (TS) – 'Use Steps'  available if V-Curve has been activated
Specific Method Settings
- Parameter of set value: Speed List – or select TruMode, Set Speed or Shear Rate
- Speed List Items: all – create, select or unselect preset speeds, which are available in the Speed List in the Manual Mode)
- Speed List: select a speed from the Speed List
- Preshear Time
- Start Set Temperature
- Stop Set Temperature
- Number of Points

- T-Ready
- disabled: Measurement starts when "Sensor ready", i.e. the internal Pt100 sensor of the PTD 80 is at set temperature.
- enabled: Additional stability criteria ensure that measurement starts only if also the sample in the cup is at set temperature.

- Target Time

>>> continues on next page


Table 2: Method settings depending on the selected measurement mode <<< continued from previous page

General Method Settings

- Display Layout (select: 4 / 5 / 6 Widgets | V-Curve3: 1 Graph + 5 or 6 Widgets)

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Standard Operating Procedure
ViscoQC 300 [with PTD 80]
SOP for Pharma Qualification Package
- Immersion Depth for spindles: Full (default) / Half – applies to V71 to V73 only
- Restrict use of spindles (enable/disable)
- Restrict to Unique Spindle Identifier (enable/disable)
- Allowed Spindles (if enabled, select from spindle list)
- Use Limits (enable/disable)
- Limits (if enabled, set limits => quantities and values)
- Use operator instructions (enable/disable):
- Operator instruction text (if enabled, enter max. 100 characters)
- Density: 1.000 g/cm³ – default value, range: 0.0000 g/cm³ to 9.9999 g/cm³
Math. Model3
Quick Settings
It depends on the settings in the User Group Administration, which users can change parameters in the quick settings. It is
possible to access the quick settings without full access rights to method settings.
- Sample Name is mandatory (enable/disable)
- Show Set Value (enable/disable)
- Set Value is mandatory (enable/disable)
- Density Input (enable/disable)
- Density Input is mandatory (enable/disable)
- Show Immersion Depth for Spindles (enable/disable)
- Immersion Depth is mandatory (enable/disable)
- Show Batch Number (enable/disable)
- Batch Number is mandatory (enable/disable)
- Show AR Number (enable/disable)
- AR Number is mandatory (enable/disable)
- Show Custom (enable/disable)
- Custom Name (enter a name for the custom field)
- Custom is Mandatory (enable/disable)

3
Choice only available if software package V-Curve has been activated

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Standard Operating Procedure
ViscoQC 300 [with PTD 80]
SOP for Pharma Qualification Package

7. When all mode settings are ready, tap <OK> to save them.

8. Tap <Home> to return to the main screen.


Figure 14: Save method settings, return to main screen

5.6 Select a Measurement Method

Select a measurement method. By default, Manual Mode is


selected.

1. Tap on button <Method> on the main screen.

2. Tap on the desired method in the list.

Figure 15: Select a method

5.6.1 Manual Mode Settings – Options


The Manual Mode offers the following options:
 Measurement using the Speed List – select from preset speeds (predefined in the method settings)
 Measurement at one set speed – set the value directly via main screen
 Measurement at one set shear rate – set the value directly via main screen
 TruMode – adjusts the speed so that ViscoQC reaches a torque of approximately 80 %. Speed range:
1 rpm to 200 rpm. If using TruMode™, ViscoQC searches for the right speed until it has reached the
desired torque and the values have been stable for at least 10 s.
NOTE
Once the desired torque and stability have been reached with a certain speed, ViscoQC uses this
measuring speed for the entire test duration. If the torque changes later during the test due to e.g. shear
thinning/thickening or temperature influences, the measuring speed is not adjusted.
If the required torque cannot be reached or the torque range is exceeded, ViscoQC displays an error and a
message in the message list recommending the use of a bigger or smaller spindle. The message also tells
if the viscosity range of the sample does not fit into the current setup, current spindle, or the torque range of
the ViscoQC model.

 On the main screen, tap the <Parameter> button. The <Set


Value> button on the right shows the current setting (default:
TruMode – speed is not preset but automatically determined).
 Select a parameter:
Speed List, TruMode, Set Speed or Shear Rate
 Select a speed from the list, or enter a set speed or shear rate
value. If not using TruMode, click directly on the <Set Value>
Figure 16: Set parameter for Manual Mode
button to change the set value.
 Tap <OK> to save your settings.
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Standard Operating Procedure
ViscoQC 300 [with PTD 80]
SOP for Pharma Qualification Package

5.6.2 [ Setting the PTD 80 measuring temperature in Manual Mode ]

 [On the main screen, tap the <Set Temperature> button. The
button shows the currently set measuring temperature.]
 [Set a measuring temperature.]
 [Tap <OK> to save your settings.]

[Figure 17: Set temperature for Manual Mode]

5.7 Performing Measurements


If available, prepare your sample according to a suitable standard test method, guide or practice.
The equipment employed for measurement must be clean and free of residues.

WARNING – Risk of injury, health risk


Using chemically or biologically hazardous chemicals as samples or cleaning liquids is a health risk.
Measuring hot (> 40 °C/104 °F) or very cold (< 0 °C/32 °F) substances is a health risk.
The above risks could cause serious injuries unless special precautions are taken. Consult the material safety data
sheets of the sample substances and cleaning liquids.
Operate the ViscoQC 300 in a fume hood and make sure to use suitable protective equipment.
Adhere to the "Safety Instructions" in the ViscoQC 300 Instruction Manual and Safety Information (C78IB007EN)
[and to the "Safety Instructions" in the ViscoQC Temperature Devices Instruction Manual and Safety Information
(C78IB012EN)].

NOTICE – Risk of damage to instrument parts


Make sure that all wetted parts are resistant to the sample substance and cleaning liquids. Refer to appendix B of
the ViscoQC 300 Instruction Manual and Safety Information.

Make sure that sample temperature is between -60 °C and +100 °C (-76 °F to +212 °F).

For open vessels (600 mL beakers):


For temperature control, use the Julabo Corio™ C-BT5 bath thermostat (see ViscoQC Temperature Devices
Instruction Manual and Safety Information, C78IB012EN). Operation of the bath is possible from ambient
temperature up to +100 °C (+212 °F) depending on the boiling point of water under local ambient conditions. If
operating at high temperatures, refill water at regular intervals to compensate evaporation.

[For DIN/SSA systems, use a PTD 80 to control the temperature from +15 °C (+59 °F) to +80 °C (+176 °F).]

Make sure that the sample will not solidify or harden inside the sample vessel. Otherwise you may have to dispose
of the spindle/measuring system and/or spindle guard.

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Standard Operating Procedure
ViscoQC 300 [with PTD 80]
SOP for Pharma Qualification Package

5.7.1 Measuring with Spindles


1. Use a sample vessel of at least 500 mL filling volume (typical
600 mL lab beaker with minimum 82.5 mm inner diameter).
Fill the sample into the test vessel. The sample should be free
of bubbles.

A sufficient sample filling height is important, because the tip


of the spindle should be at least 10 mm above the vessel’s
bottom and should be immersed as far as the mark on its
shaft.

TIP: L1 spindle requires more than 500 mL of sample volume or the


use of a labor boy is recommended.

Recommended filling volume for vane spindles:


 V71: 500 mL / 300 mL4 (600 mL beaker)
 V72: 350 mL / 250 mL4 (400 mL beaker)
 V73: 200 mL / 160 mL4 (250 mL beaker)
 V74: 20 mL (25 mL beaker)
Figure 18: Fill sample, insert spindle guard and
spindle  V75: 60 mL (100 mL beaker)

2. If using a spindle guard, immerse that first (then the spindle).

3. Slowly dip the spindle into the sample vessel. Incline disc
spindles so that you do not trap air bubbles on the bottom
side of the spindle.

4
Immersion depth: full / half – Vane spindles V71 to V73 have two immersion marks (full and half). SMC (Spindle
Multiplier Constant, see ViscoQC 300 Instruction Manual and Safety Information, C78IB007EN) of full immersion is
used for calculation of viscosity by default. If only low sample volume is available and half immersion of V71 to V73
is needed, the correct immersion depth must be set in the method settings (see Table 1). The recommended speed
range for vane spindles is up to 10 rpm. Above 10 rpm turbulences (Eddy currents) might cause higher viscosity
readings. For yield stress determination (with V-Curve only), the maximum recommended speed is 5 rpm.
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Standard Operating Procedure
ViscoQC 300 [with PTD 80]
SOP for Pharma Qualification Package

4. Put the sample vessel beneath the measuring head. Move


the ViscoQC measuring head slowly downwards until it nearly
touches the spindle. Pull the spindle upwards and fix it on the
measuring head.

5. If applicable, mount the spindle


guard on the rear of the
measuring flange with the
supplied screw.

Figure 22: Connect the spindle guard

6. Adjust the height of the measuring head: immerse the spindle


until the sample level reaches the mark (small recess) on the
spindle shaft. Adjust the position of the sample vessel: the
spindle must be centered.
Figure 19: Connect the spindle

TIP: The beaker can be positioned exactly centrally to the spindle by


using the flexible cup holder.

Figure 20: Flexible cup holder

Figure 21: Screen header shows the connected


spindle

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Standard Operating Procedure
ViscoQC 300 [with PTD 80]
SOP for Pharma Qualification Package

If applicable, place the optional Pt100 sensor in the sample vessel.

1. Plug the Pt100 sensor into the connector on the rear of


ViscoQC.

2. Fit the guide on the Pt100 plug into the recess of the socket.

3. Immerse the Pt100 sensor in the sample vessel. Fix the


Pt100 sensor on the rim of the sample vessel or on the L/R
guard with the metal clip.

Figure 23: Fix the Pt100 sensor on the spindle


guard or on the sample vessel

5.7.2 Measuring with DIN/SSA Systems

1. For DIN (concentric cylinders CC or double-gap DG) / SSA


(SC4 spindles in CC18 cup) systems, mount the DIN adapter
on the measuring head.

TIP: If in use, insert the optional Pt100 sensor from above into the
bore of the DIN adapter before mounting the DIN adapter.

2. Fill the sample into the provided cup up to the mark or use the
recommended sample filling volume. Proceed slowly to avoid
air bubbles.

 CC12: 2 mL
Pt100  CC18: 6.4 mL
 CC26: 18.5 mL
 CC12/D18: 11.8mL (system with disposable cup)
 DG26 or DG26/SS: 7.5 mL
 SC4-18: 6.7 mL
 SC4-21: 7.1 mL
 SC4-27: 10.4 mL

3. Dip the selected measuring bob into the sample substance.


4. Insert the cup into the DIN adapter from below until it clicks.
The upper rim of the cup is now at the same height as the rim
of the DIN adapter.
5. Rotate the cup until the notch on its rim clicks into place (see
arrows).
6. Pull the measuring bob upwards and fix it on the measuring
Figure 24: Mount the DIN adapter and DIN/SSA head. Place the optional cover on the cup.
measuring system (with optional Pt100 sensor)

Define a Spindle Correction Factor for each DIN/SSA system in order


to achieve measuring accuracy better than ±3 %. See Instruction
Manual and Safety Information, C78IB001EN.

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Standard Operating Procedure
ViscoQC 300 [with PTD 80]
SOP for Pharma Qualification Package

5.7.3 [Measuring with DIN/SSA Systems with PTD 80]

1. [Move the ViscoQC measuring head upwards so that there is


enough room to mount the centering adapter on the ViscoQC
1
measuring head.]

2. [Slide the adapter over the measuring flange and fasten it


with the attached screw (1 – right thread).]

[Figure 25: Mount the centering adapter of PTD 80]

3. [Fill the sample into the provided cup up to the mark or use
the recommended sample filling volume. Proceed slowly to
avoid air bubbles.]

 [CC12: 2 mL
 CC18: 6.4 mL
 CC26: 18.5 mL
 CC12/D18: 11.8 mL (system with disposable cup)
 DG26 or DG26/SS: 7.5 mL
 SC4-18: 6.7 mL
 SC4-21: 7.1 mL
 SC4-27: 10.4 mL]

4. [Dip the selected measuring bob into the sample substance.]

5. [Slide the measuring cup lock over the measuring cup. It must
snap into the groove of the cup, so that it is level with the
cup’s upper rim (see arrows).]

[Figure 26: Mount the measuring cup lock]

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Standard Operating Procedure
ViscoQC 300 [with PTD 80]
SOP for Pharma Qualification Package

CLICK !
6. [Rotate the cup until the notch on its rim clicks into place
(catching the positioning screw on the measuring cup lock).]

[Figure 27: Fit the measuring cup lock on the cup]

7. [Insert the measuring cup from above into the PTD 80 heating
tube.]

8. [Rotate the cup until the measuring cup lock clicks into place
on the positioning pin. (The measuring cup lock has a bore
hole on its bottom side).]

[The measuring cup is correctly positioned:


 if there is no gap between the surface of the PTD 80 and the
measuring cup lock and
 if you cannot turn the measuring cup any more.]
[Figure 28: Place the measuring cup in the PTD 80]

9. [Move the measuring head slowly downwards until the


centering adapter touches the surface of the PTD 80. The
three legs of the centering adapter align the PTD 80 in
relation to the measuring head.]

[Figure 29: The centering adapter centers the


PTD 80 in relation to the ViscoQC measuring head]

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Standard Operating Procedure
ViscoQC 300 [with PTD 80]
SOP for Pharma Qualification Package

[TIP: Lower the measuring head carefully. The centering adapter shall
touch the PTD 80 surface, but not press down on the PTD 80.
If you lower the measuring head too far, the PTD 80 base plate bends
and the device is no longer leveled. ViscoQC will display a warning
(yellow "Warning" sign – see message list). ]

[Figure 30: The three legs of the centering adapter


shall not press down onto the PTD 80 surface.]

10. [Pull the measuring bob upwards and fix it on the measuring
head. Place the optional cover on the cup.]

[Define a Spindle Correction Factor for each DIN/SSA system in order


to achieve measuring accuracy better than ±3 %. See Instruction
Manual and Safety Information, C78IB001.]

[The main screen header shows that a PTD 80 is connected


(thermometer symbol) and the connected spindle.]
[The PTD 80 temperature field on the main screen shows the set
temperature (small numbers), the current temperature (large
numbers), and whether T-Ready is active (label)].

[Figure 31: Main screen header – PTD 80 [ ]


connected]
[Figure 32: PTD 80 temperature field]

5.7.4 Measurement Procedure

1. Tap <Start > on the main screen to start measuring. The


display depends on the selected measurement method.

2. For Manual Mode, also tap this button to finish the test.

Figure 33: Start measurement – Example Manual


Mode [no PTD 80 in use]

1. When starting a measurement, ViscoQC has to reach stable conditions first.

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Standard Operating Procedure
ViscoQC 300 [with PTD 80]
SOP for Pharma Qualification Package

 [ViscoQC waits that the PTD 80 reaches the set temperature The progress bar is red and in motion and
reads "Waiting for Sensor Ready". The spindle does not turn. ViscoQC starts the motor when status
"Sensor Ready" was reached. During heating or cooling, the LED of the PTD 80 blinks.]
 [If T-Ready is enabled: ViscoQC waits for temperature equilibrium of the sample. The spindle turns at
set speed (this improves the temperature equilibrium) and the progress bar reads "Waiting for T-
Ready".]
 Until ViscoQC reaches the set speed (for TruMode™, this is the speed that gives the target torque) the
progress bar is red and in motion and reads "Preparing". The counter starts at once, but the runtime is
not yet counting.
2. When the spindle turns at set speed [and sample equilibrium (T-Ready) was reached], ViscoQC starts
taking the time. After preparation and optional preshearing: The progress bar is red and in motion. It says
"Measuring". The runtime starts counting.

If no Pt100 sensor or no temperature device is connected, the temperature reading is " --- ".

 The valid torque range is between 10 % and 100 %, ideally between 80 % to 95 %: dynamic viscosity and
torque values appear black
 Torque < 10 %: dynamic viscosity and torque values appear gray
 Torque < 0 %: " ---" – no dynamic viscosity value shown
 Torque < -10 %: "<<<" shown as torque value
 Torque > 100 %: ">>>" shown as torque value

5.7.4.1 Measuring in Manual Mode (MM)

In the Manual Mode, you can alter the measuring speed while a
measurement is running. Exception: TruMode™.

 Tap the <Set Value> button (set value = speed or shear rate)
 Select a new speed from the list, or enter a set speed or shear
rate.
 Tap <OK> to save your setting.

Figure 34: Set speed / shear rate during manual


measurement

[Further, with PTD 80, you can alter the measuring temperature while
a measurement is running.]

 [Tap the <Set Temperature> button.]


 [Set a new measuring temperature.]
 [Tap <OK> to save your setting.]
[Figure 35: Set PTD 80 temperature during manual
measurement]

The status of the progress bar can change from "Measuring" back to
"Preparing" [ or "Waiting for Sensor Ready" / "Waiting for T-Ready". ]

TIP: In order to get reliable measuring values, the spindle should have completed at least five revolutions before a
value is accepted. In case you do not manually stop the test, your settings should agree with this rule (especially if
the measuring speed is low).
Guideline:  for measuring speed > 5 rpm at least 20 s measuring time
 for measuring speed < 5 rpm at least 60 s measuring time

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Standard Operating Procedure
ViscoQC 300 [with PTD 80]
SOP for Pharma Qualification Package

3. When the measurement is ready, the progress bar turns


green and says "Finished". The message list button shows a
green check sign. The counter shows the duration of the total
test procedure. The runtime shows the duration of the actual
measurement. All measured values are frozen on the screen.

If an error or warning occurs, the progress bar is red. The message


list button shows a yellow warning or a red error sign.
Figure 36: Measurement finished (example Manual If the message list contains one or several messages, the message
Mode[, no PTD 80]) – view measured data list button displays a small yellow note with the number of messages.

Figure 37: Example – Message list


4. To view measured data, tap the button <Measured Data> on
button, Warning, 1 message in list the main screen or select "Menu > Data Memory > Measured
Data".
The multiple sample view shows a list of all measurements.
In the first column of the multiple sample view, you find an icon for each measured sample.
The icon indicates the status of the sample:
Sample successfully measured
Warning
No result due to a malfunction
Measurement aborted

 Tap a measurement to view details.


 You can select and print/export (by default only with
administrator/manager rights) data. Tap <More> or perform a
long press on a measurement to access these options.

NOTE: If automatic printout via V-Collect software is active, access to


data memory on the touch screen is not possible.

Figure 38: Example – Multiple sample view

5. To unfreeze the screen after measurement, tap .

6. If you stop a measurement before ViscoQC has finished "Preparing" or before it has reached a target
value, the progress bar is red and reads “Finished”. Data are not sent to the USB printer (if in use). The
status in the Measured Data view is "aborted".

7. When you have finished, remove all parts.

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Standard Operating Procedure
ViscoQC 300 [with PTD 80]
SOP for Pharma Qualification Package

5.8 Cleaning
5.8.1 Removing and Cleaning Wetted Parts

WARNING – Risk of injury, health risk


If you measured at very high or low temperatures, wait until the
sample reaches a temperature between 15 °C and 40 °C (59 °F and
104 °F) before you handle the hot or cold parts or make sure to use
suitable protective equipment. Using chemically or biologically
hazardous chemicals as cleaning liquids is a health risk. Clean parts
in a fume hood and make sure to use suitable protective equipment.

Figure 39: Remove spindle and spindle guard


1. Unscrew the spindle guard (if used) and disconnect the
spindle. Take the spindle shaft beneath the coupling and
incline the spindle sideways. Then pull the spindle
downwards.
If using the DIN Adapter:
 For DIN/SSA systems (with/without disposable cup), first
disconnect the measuring bob.
 Then turn the cup to unlock it from the DIN adapter and
pull the cup downwards.

[If using PTD 80:]


Figure 40: Remove wetted parts from the sample
for cleaning  [For DIN/SSA systems (with/without disposable cup), first
disconnect the measuring bob.]
 [Move the ViscoQC measuring head upwards. Lift the
measuring cup plus measuring cup lock out of the
PTD 80.]
 [Then remove the measuring bob from the measuring
cup.]
 [Turn the cup to unlock it from the measuring cup lock
and remove the measuring cup lock by turning and
pulling.]

2. Put the sample vessel aside and take all parts (spindle, if
applicable: spindle guard and Pt100 sensor) out of the
sample substance for cleaning.

TIP: Do not let the sample dry on the wetted parts. Clean all wetted
parts immediately.
3. First, wipe the part with dry paper. Wet a fresh sheet of paper with cleaning liquid and wipe the part again.
If the sample is hard to remove, immerse the part except for the Toolmaster™ chip in cleaning liquid. Let
the part soak for some time before wiping it.

4. You can also clean the parts with a soft sponge or soft brush.

5. If necessary, clean the parts again with a second cleaning liquid.

6. Empty the sample vessel and clean it. Proceed as described above. For DIN/SSA cups, pull off the bottom
(DG cup: unscrew the bottom and then pull) and clean the parts separately. Lift disposable cups out of the
holder and dispose of them (see point 6). Clean the holder if required.

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Standard Operating Procedure
ViscoQC 300 [with PTD 80]
SOP for Pharma Qualification Package

7. Dispose of sample substance and contaminated paper according to the regulations of your country.
Consult the material safety data sheets of the sample substances and cleaning liquids.

8. If you need to clean the Toolmaster™ chip, use a soft tissue and wet it with e.g. ethanol, isopropyl alcohol
or petroleum benzine. Wipe the chip.

NOTICE
 Do not immerse the Toolmaster™ chip on the top of a spindle coupling into liquids. Do not place the
Toolmaster™ chip in an oven at 70 °C (158 °F) or higher.
 Do not immerse the Pt100 sensor deeper than the end of the sensor sleeve. The sensor cable must not be
immersed.

[If using PTD 80:]


 [Clean the centering adapter and measuring cup lock with the same cleaning agent as used for the
measuring system.]
 [The ViscoQC Temperature Devices Instruction Manual and Safety Information (C78IB012EN) specifies all
materials of the PTD 80. Ensure that the used cleaning liquid does not damage the centering adapter or
measuring cup lock.]
 [Wipe these parts as described above.]

5.8.2 Cleaning the Instrument

To clean the housing and touch screen, use a soft cloth dipped in ethanol or warm water. If necessary, you can use
a mild solvent (pH < 10).

5.8.2.1 [Cleaning PTD 80]

[WARNING – Hot surface. Risk of injury.


If measuring at high temperatures, the PTD 80 cover is hot. Do not touch the hot surface! Do not use flammable
cleaning agents on a hot surface!]

[To wipe housing and base plate, use a soft cloth dipped in ethanol, petroleum benzine or warm water (optionally
plus a mild solvent, pH < 10).]

[NOTICE – Risk of damage to the housing.


Wiping the housing with acetone can discolor the front foil. If using any other cleaning agents than specified in the
ViscoQC Temperature Devices Instruction Manual and Safety Information, make sure they do not damage the
materials of the housing.]

6 Documentation
The user is responsible for the content and the updates of this documentation.

7 Safety and Environmental Details


Read and adhere to the Chapter “Safety Instructions” in the ViscoQC 300 Instruction Manual and Safety
Information (C78IB007EN)[ and in the ViscoQC Temperature Devices Instruction Manual and Safety Information
(C78IB012EN) ].
Find all specifications referring to ambient conditions in the appendix “Technical Data” of the ViscoQC 300
Instruction Manual and Safety Information (C78IB007EN) )[ and of the ViscoQC Temperature Devices Instruction
Manual and Safety Information (C78IB012EN) ].

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Standard Operating Procedure
ViscoQC 300 [with PTD 80]
SOP for Pharma Qualification Package

8 References
ViscoQC 300 Instruction Manual and Safety Information (Original Instructions) Document No. C78IB007EN

Reference Guide LIMS Bridge – LIMS Communication Software Document No. XPSIB005EN

ViscoQC Temperature Devices
Instruction Manual and Safety Information (Original Instructions) Document No. C78IB012EN

9 Modification Index
Version Modification Date of release
A New document 07.12.2018
Added temperature device PTD 80 as option.
Text referring to PTD 80 is put in square
brackets.
Added SSA measuring systems (Small
Sample Adapter consisting of SC4 spindles in
CC18 cup).
Screen shots adapted to ViscoQC software
version 1.10.xx.
B 05.06.2019
LIMS Bridge Reference Guide updated (new
document number).
Larger label (36 x 89 mm instead of
28 x 89 mm) for Label Printer USB
Dymo® 450. New label also shows date/time,
and user name.
Filling volume of measuring system DG26
changed from 7 mL to 7.5 mL.

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